The Recall Desk
LowFDA (Devices)·Z-2414-2025·Announced 2025-09-03

Philips XL14-3 Transducer Probes recalled for labeling clarification on useful life

Philips Ultrasound is recalling 171,322 XL14-3 Transducer Probes for labeling clarification to define the product's useful life in the field.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This FDA Class III recall addresses labeling clarification regarding product useful life. FDA Class III recalls are typically scored 1 or 2 per the severity rubric. The correction is documentary and clarification in nature, placing it in the Low severity category.

Plain-English summary

Philips Ultrasound, Inc is recalling 171,322 XL14-3 Transducer Probes distributed nationwide in the United States.

The recall is being issued to provide clarification and labeling defining the useful life of ultrasound transducers in the field.

Healthcare professionals and facilities with affected units should contact Philips Ultrasound, Inc regarding the labeling clarifications for this product.

The recalled product

Product
XL14-3 Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Hazard
  • labeling-clarification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. 989605409251
  • 989605492481
  • UDI: (01)00884838074613(21)B372N5
  • (01)00884838074613(21)F02DPY
  • (01)00884838074613(21)B3MY7N
  • (01)00884838074613(21)B3823F
  • (01)00884838074613(21)B3823J
  • 010088483807461321F026YH
  • (01)00884838074613(21)F03KJH
  • (01)00884838074613(21)F03G0Y
  • (01)00884838074613(21)F03MFH
  • (01)00884838074613(21)F03MFL
  • (01)00884838074613(21)F03MFN
  • (01)00884838074613(21)F09RZ3
  • (01)00884838074613(21)F07HBJ
  • (01)00884838074613(21)F0HDCN
  • (01)00884838074613(21)B3KTRR
  • (01)00884838074613(21)B33MYL
  • (01)00884838074613(21)B2DYZ8
  • (01)00884838074613(21)F009PY

Distribution

Distributed nationwide across the United States.